Medicines Repurposing Program - Eligibility criteria and application process

Eligibility criteria for nomination

To be eligible for consideration under the Medicines Repurposing Program (MRP, the program), the nominated candidate medicine must:

• Be a prescription medicine that is registered on the Australian Register of Therapeutic Goods (ARTG)
• Propose a new and distinct indication (i.e., use is for a different medical condition or new patient group), and
• Have in-principle support for nomination and consideration by the program from a relevant pharmaceutical sponsor.

Medicines that do not meet the eligibility criteria will not be considered for the program.

Evidence requirements

Candidate medicines selected through the program will be offered application and evaluation fee waivers for the registration of an extension of indications (Category 1, Type C) for an existing ARTG registered medicine. This pathway is an existing application pathway and the same evidence requirements and standards apply, as for any other extension of indication application.

Further information on this pathway and requirements can be found on our website:

• Extension of indication prescription medicines application process
• Prescription medicines registration process.

In general, high-quality evidence would consist of randomised controlled trials (RCTs), demonstrating a clear benefit for use of the medicine for the proposed indication (efficacy). An alternative way to support registration, particularly for older medicines, where RCTs for the proposed indication may not have been conducted, is through a literature based submission.

Evidence based clinical guidelines can be of value in identifying whether there is sufficient evidence to support registration of a proposed indication. However, it is important to consider both the level of the evidence (e.g. clinical trials, meta-analyses, observational studies or expert consensus) on which recommendations are based, as well as the strength of the recommendation. Most clinical guidelines will provide ratings, detailing this information for each recommendation made. Clinical guidelines are not sufficient on their own to support an application for registration of a new indication.

Advice from the Advisory Committee on Medicines (ACM)

The program will seek advice from the Advisory Committee on Medicines to confirm the clinical need for the candidate in the Australian context. Feasibility to repurpose a medicine will also be considered, to best realise benefits to patients.

PBS subsidy consideration through PBAC

Candidates selected under the program may also be eligible for fee waivers for Pharmaceutical Benefits Advisory Committee (PBAC) application and evaluation processes. Applications are considered under existing PBAC submission pathways. Further information on eligibility criteria and the application process for consideration of a PBAC fee waiver can be found on the Pharmaceutical Benefits Scheme - Cost Recovery Fees and charges - external site webpage.

Decisions on nominated medicines

Each assessment results in one of the following outcomes:

• Selected for repurposing: The program offers the sponsor of the selected medicine waivers for TGA application and evaluation fees for registration of the extension of indication. Subsequent waivers for evaluation fees for submissions for listing on the PBS may also be available for selected candidates. Selection for repurposing does not guarantee TGA approval of the new use (extension of indication) or PBS listing (subsidy). Applications will be evaluated as per standard pathways by the TGA and PBAC.
• Unsuitable for repurposing: These applications are assessed as unsuitable, due to insufficient evidence to demonstrate efficacy for the proposed new use, or a lack of sponsor interest. In the event of any new development or significant change in either aspect, the medicine can be re-nominated with the new evidence. However, re-nomination does not guarantee any specific outcome or future selection for repurposing.

As the selection process involves multiple processes with variable timeframes, an overall timeframe, from nomination to selection, is unable to be provided.

Contact

For all enquiries and to discuss program eligibility requirements please email mrp@health.gov.au.